Trial Title:
TQB2618 Injection Combined With Penpulimab Injection in the Treatment of Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
NCT ID:
NCT05563480
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Cisplatin
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2618 Injection, Pempulimab Injection, Cisplatin Injection, Gemcitabine Hydrochloride Injection
Description:
TQB2618 injection: Anti-TIM-3 monoclonal antibody; Penpulimab injection: Humanized
Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1)
Arm group label:
TQB2618+Pempulimab+Chemotherapy
Intervention type:
Drug
Intervention name:
Penpulimab injection, Cisplatin Injection, Gemcitabine Hydrochloride Injection
Description:
Penpulimab injection: Humanized Monoclonal Antibody to Programmed Cell Death Protein 1
(PD-1)
Arm group label:
Penpulimab + Chemotherapy
Intervention type:
Drug
Intervention name:
TQB2618 injection; Penpulimab injection
Description:
TQB2618 injection: Anti-TIM-3 monoclonal antibody; Penpulimab injection: Humanized
Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1)
Arm group label:
TQB2618+Pempulimab
Summary:
This is a phase II clinical trial to evaluate the efficacy and safety of TQB2618
injection combined with Penpulimab in patients with recurrent/metastatic nasopharyngeal
carcinoma.
This study is divided into two parts. The first part includes the safe introduction phase
and the expansion phase. The second part is a randomized controlled study design, which
is divided into two groups. The two parts of research are carried out at the same time
Detailed description:
This study is divided into two parts:
The first part includes the safe introduction phase and the expansion phase. All the
patients with advanced nasopharyngeal carcinoma who failed to be treated with platinum
chemotherapy and immunocheckpoint inhibitors (anti-PD-1 monoclonal antibody/anti-PD-L1
monoclonal antibody, etc.) were enrolled. The treatment scheme is TQB2618 + Penpulimab
Injection. During the safe introduction period, we explored whether the two dose groups
(1200mg/1500mg) were safe and tolerable when TQB2618 was combined with Penpulimab
Injection. If the two dose groups are tolerable, 18~24 patients in the second phase of
the extended study were randomized to receive TQB2618 in two dose groups
(1200mg/1500mg)+Penpulimab Injection (200mg) at a ratio of 1:1. If high dose (1500mg) of
TQB2618 is not tolerated, all patients will receive TQB2618 (1200mg)+Penpulimab Injection
(200mg).
The second part is a randomized controlled study design, which is divided into two
groups. All the newly treated patients with advanced nasopharyngeal carcinoma who have
not received systematic treatment in the past received TQB2618+Penpulimab Injection+GP
chemotherapy and paianzulimab+GP chemotherapy respectively. The dose of TQB2618 was
1200mg.
The two parts of research are carried out at the same time.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed nasopharyngeal carcinoma, stage IVb as
defined by the AJCC TNM staging system for nasopharyngeal carcinoma, 8th edition in
2017 or subjects with recurrent nasopharyngeal carcinoma who were not suitable for
local therapy (For neoadjuvant/adjuvant therapy and radical concurrent
chemoradiotherapy, if the disease progresses during treatment or within 6 months
after the treatment completion, it should be counted as a failure of first-line
treatment of the original plan, and if it exceeds 6 months, it cannot be counted as
first-line treatment failure. Alterations of treatment regimen due to drug
intolerance are not defined as treatment failure).
- The first part of enrolled patients shall also meet the following requirements:
1. At least received first-line treatment for recurrent/metastatic lesions, and
the last anti-tumor treatment before enrollment had evidence of imaging
progress in line with RECIST 1.1 standard;
2. At least have received platinum containing chemotherapy and immunocheckpoint
inhibitors (anti-PD-1 monoclonal antibody/anti-PD-L1 monoclonal antibody, etc.)
in the past and failed treatment, and there is evidence of imaging progress
that meets the RECIST 1.1 standard. Platinum containing chemotherapy and
immunotherapy can be used during palliative treatment for recurrent/metastatic
lesions, or during radical treatment for locally advanced diseases.
3. Immunotherapy for recurrent/metastatic lesions shall not exceed 2 lines (For
neoadjuvant/adjuvant therapy and radical concurrent chemoradiotherapy, if the
disease progresses during treatment or within 6 months after the treatment
completion, it should be counted as a failure of first-line treatment of the
original plan, and if it exceeds 6 months, it cannot be counted as first-line
treatment. Failure. Alterations of treatment regimen due to drug intolerance do
not defined as treatment failure
4. For the latest immunotherapy before enrollment, if it is aimed at
recurrence/metastasis, the best efficacy is at least SD (≥ 6 weeks) or
confirmed PR or immunotherapy duration ≥ 12 weeks.
- The second part of the enrolled patients also need to meet the following
requirements:
1. Have not received systemic antitumor therapy for recurrent/metastatic
nasopharyngeal carcinoma before;
2. No previous treatment with immune checkpoint inhibitors (anti PD-1 monoclonal
antibody/anti PD-L1 monoclonal antibody, etc.). Those who have used no more
than one immune checkpoint inhibitor (limited to CTLA-4/PD-1/PD-L1 monoclonal
antibody, not including bispecific antibody, not including Penpulimab
injection) in the stage of locally advanced radical treatment can be included
if they meet the following criteria:
1. If used in the induction phase (with or without other drugs), the best
effect in the induction phase is at least PR;
2. If used during radical radiochemotherapy/radiotherapy or subsequent
maintenance stage, there is no progress during treatment and within one
year after stopping treatment
- At least one measurable lesion confirmed according to RECIST 1.1 criteria;
- The function of main organs are well and meet the following standards:
1. Routine Blood routine examination standards (without blood transfusion or
correction with hematopoietic stimulating factor drugs within 14 days before
the examination):
1. Hemoglobin (HGB) ≥90 g/L;
2. Absolute value of neutrophil (NEUT) ≥1.5×109/L;
3. Platelets count (PLT) ≥ 100×109/L.
2. The biochemical examination shall meet the following standards:
1. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)
(Patients with Gilbert syndrome ≤ 3 × ULN);
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5
× ULN. If it is accompanied by liver metastasis, ALT and AST ≤ 5 × ULN;
3. Serum creatinine (CR) ≤ 1.5 × ULN or Creatinine clearance (CCR) ≥ 60
ml/min;
3. Blood coagulation function or thyroid function test should meet the following
standards: Prothrombin time (PT), activated partial thromboplastin time (APTT),
international normalized ratio (INR)≤1.5×ULN (no anticoagulant therapy);
4. Thyroid Stimulating Hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should
be examined. If T3 and T4 levels are normal, it can be selected.
5. Heart color Doppler ultrasound assessment: Left ventricular ejection fraction
(LVEF) ≥50%.
- Female subjects of reproductive age should agree that they must conduct
contraceptive measures (such as intrauterine devices, contraceptives, or condoms)
during and for 6 months after the study; Female subjects should have a negative
serum/urine pregnancy test within 7 days prior to study enrollment and must be
non-lactating; Male subjects should agree that they must conduct contraception
during the study period and for 6 months after the study.
Exclusion Criteria:
- Combined diseases and medical history:
1. Other malignant tumors have occurred or are currently suffering from other
malignant tumors within 5 years before the first medication, except for fully
treated non-melanoma skin cancer, cervical carcinoma in situ and papillary
thyroid carcinoma;
2. Unresolved toxicities greater than CTC AE grade 1 due to any prior therapy,
excluding alopecia, neurotoxic sequelae associated with prior platinum therapy;
3. Received major surgical treatment, obvious traumatic injury (excluding needle
biopsy, endoscopic biopsy, etc.) within 28 days before the first drug;
4. Arterial/venous thrombotic events, such as cerebrovascular accident (including
transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein
thrombosis and pulmonary embolism, occurred within 6 months before the first
drug;
5. Active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis,
organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring
treatment, or active pneumonia with clinical symptoms;
- Cancer-related symptoms and treatment:
1. Received NMPA-approved Chinese patent medicines with anti-tumor indications in
the drug insert within 2 weeks prior to the first administration;
2. Received surgery, chemotherapy, radiotherapy or other anti-cancer therapy
within 3 weeks before the start of study treatment (the washout period is
calculated from the end of the last treatment); those who have received local
radiotherapy in the past can be enrolled if they meet the following conditions:
radiotherapy The end of the study treatment is more than 3 weeks (more than 2
weeks for brain radiotherapy); and the target lesions selected in this study
are not in the radiotherapy area; Or the target lesion is located in the
radiotherapy area, but the progress has been confirmed.
3. Previous treatment with anti-TIM-3 antibodies;
4. The nasopharyngeal lesions recurred after radiotherapy and received
Re-radiotherapy;
5. maging (CT or MRI) shows that the tumor has invaded around important blood
vessels, and it is judged by the investigator that the tumor is very likely to
invade important blood vessels and cause fatal hemorrhage during the follow-up
study;
6. Uncontrolled pleural effusion, pericardial effusion or ascites requiring
repeated drainage;
7. Known uncontrolled or symptomatic active central nervous system (CNS)
metastases presenting with clinical symptoms, cerebral edema, spinal cord
compression, cancerous meningitis, leptomeningeal disease, and/or progressive
growth. Patients with a history of CNS metastases or spinal cord compression
were eligible if they were clearly treated and clinically stable after 4 weeks
of discontinuation of anticonvulsants, steroids, or dehydrating agents prior to
the first dose of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510100
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Ma, Doctor
Phone:
+86 13078892696
Email:
majun@sysucc.org.cn
Facility:
Name:
The Fifth Affiliated Hospital Sun Yat sen University
Address:
City:
Zhuhai
Zip:
519000
Country:
China
Status:
Recruiting
Contact:
Last name:
Siyang Wang, Master
Phone:
13570608929
Facility:
Name:
Union Hospital Tongji Medical College, Huazhong University Of Science And Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Kunyu Yang, Doctor
Phone:
+86 13995595360
Email:
Yangky71@aliyun.com
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Zip:
410078
Country:
China
Status:
Recruiting
Contact:
Last name:
Liangfang Shen, Doctor
Phone:
+86 13975805137
Email:
slf1688@sina.com
Start date:
October 27, 2022
Completion date:
May 2024
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05563480
